Treatment of the vertebral column

ABSTRACT

A method is provided for treating a spinal condition. The method includes introducing a biological treatment into an area of a vertebral column, and mechanically unloading the treated area by applying a load-bearing device to the anterior region, the anterior column region, the posterior region, or the spinous process region of the vertebral column.

BACKGROUND

The present application relates generally to treatment of the vertebralcolumn, for example, repairing or regenerating an area of the vertebralcolumn, or reducing or preventing degeneration of an area of thevertebral column.

Disease, degradation, and trauma of the spine can lead to variousconditions that require treatment to maintain, stabilize, or reconstructthe vertebral column. For example, degeneration of the facet jointsand/or the intervertebral discs due to aging and/or trauma can lead topain, neurological deficit and/or loss of motions that require treatmentto maintain, stabilize, reconstruct and/or regenerate the degeneratedlevels. Repair/regeneration of such levels via a biological approach istechnically challenging at least in part because of the high loadingenvironment present in such levels. Reducing or preventing degenerationof an area of the vertebral column can be similarly challenging.

SUMMARY

The present application relates generally to treatment of the vertebralcolumn, for example, repairing or regenerating an area of the vertebralcolumn, or reducing or preventing degeneration of an area of thevertebral column.

In one embodiment, a method of treating a vertebral column includesintroducing a biological treatment into an area of a vertebral column,and at least partially mechanically unloading the treated area. In oneaspect, the treated area is mechanically unloaded by applying aload-bearing device to at least one region of the vertebral column. Incertain aspects, the load-bearing device is applied to an anteriorregion, an anterior column region, a posterior region, or a spinousprocess region of the vertebral column.

In another embodiment, a method of treating a vertebral column includesintroducing a biological treatment into a facet joint in a vertebralcolumn, and at least partially mechanically unloading the treated facetjoint. In one aspect, the treated facet joint is at least partiallymechanically unloaded by applying a load-bearing device to an anteriorcolumn region adjacent to the treated area.

In another embodiment, a method of treating a vertebral column includesintroducing a biological treatment into a disc space in a vertebralcolumn, and at least partially mechanically unloading the treated discspace. In one aspect, the treated disc space is unloaded by applying aload-bearing device to an anterior column region adjacent to the treatedarea.

In another embodiment, a method for treating a motion segment of avertebral column includes accessing a portion of the patient's spinalcolumn, implanting a load-bearing device into the motion segment, andinjecting a biological treatment into the motion segment. Theload-bearing device at least partially mechanically unloads the motionsegment. In one such embodiment, the motion segment of the vertebralcolumn is intact.

Additional embodiments are provided in the following description and theattached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a sagittal view of a motion segment of a vertebral column.

FIG. 2 is a superior view of a vertebral body depicted in FIG. 1.

FIGS. 3-4 illustrate methods for applying a biological treatment to afacet joint in a vertebral column.

FIGS. 5-6 illustrate methods for applying a biological treatment to adisc space in a vertebral column.

FIGS. 7A-7F illustrate methods for applying a biological treatment to avertebral body and/or an endplate.

FIGS. 8A-8C illustrate alternative methods for applying a biologicaltreatment to a disc space in a vertebral column.

FIGS. 9-10 are sagittal views of a motion segment of a vertebral columnto which a biological treatment has been applied in combination with amechanical unloading device.

DETAILED DESCRIPTION

The present disclosure relates generally to treatment of the vertebralcolumn, for example, repairing or regenerating an area of the vertebralcolumn, or reducing or preventing degeneration of an area of thevertebral column.

Certain embodiments describe methods for treating motion segments of thespinal column and components thereof. Such embodiments include but arenot limited to treating facet joints, intervertebral discs, vertebralbodies and endplates using a biological approach in combination with amechanical unloading device that is at least partially load-bearing withrespect to the treated area such that it at least partially unloads thetreated area.

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments, or examples,illustrated in the drawings and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of the invention is thereby intended. Any alterations andfurther modifications in the described embodiments, and any furtherapplications of the principles of the invention as described herein arecontemplated as would normally occur to one skilled in the art to whichthe invention relates.

Referring now to FIGS. 1 and 2, the reference numeral 10 refers to amotion segment of a vertebral column. Motion segment 10 comprises anintervertebral disc 25 and a facet joint 26. Motion segment 10 may beconsidered as having several regions extending from anterior toposterior. These regions include an anterior region 12, an anteriorcolumn region 14, a posterior region 16, and a spinous process region18. The anterior column region 14 may be further considered to haveseveral regions extending longitudinally along the column. These regionsinclude a vertebral body region 20, an endplate region 22, and a discspace region 24. Disc space region 24 includes the nucleus and annulusforming intervertebral disc 25.

Any of the regions illustrated in FIGS. 1 and 2 may benefit from abiological treatment as described herein. In certain embodiments, thebiological treatment is non-load bearing. In certain aspects, a non-loadbearing biological treatment comprises a composition that is appliedwithout an associated support or structure. Treatment/treating of thevertebral column includes repair and/or regeneration of a degeneratedarea of the vertebral column, and/or reduction or prevention ofdegeneration of an area of the vertebral column. Methods for treatingthe vertebral column with a biological treatment and a device that is atleast partially load-bearing with respect to the treated area such thatthe device at least partially mechanically unloads the treated area aredescribed herein.

As used herein, a “biological treatment” includes but is not limited toa “biologically active component”, with or without a “biologicaladditive”.

A “biologically active component” includes but is not limited toanti-cytokines; anti-interleukin-1 components (anti-IL-1); anti-TNFalpha; “growth factors”; LIM mineralization proteins; “stem cellmaterial”, autogenic chondrocytes; allogenic chondrocytes, such as thosedescribed in U.S. Patent Application Publication No. 2005/0196387, theentire disclosure of which is incorporated herein by reference;autogenic chondrocytes with retroviral viral vector or plasmid viralvector; allogenic chondrocytes with retroviral viral vector or plasmidviral vector; and fibroblasts. The acronym “LIM” is derived from thethree genes in which the LIM domain was first described. The LIM domainis a cysteine-rich motif defined by 50-60 amino acids with the consensussequence CX₂C₁₆₋₂₃HX₂CX₂CX₂CX₁₆₋₂₁CX₂(C/H/D), which contains two closelyassociated zinc-binding modules. LIM mineralization proteins include butare not limited to those described in U.S. Patent ApplicationPublication No. 2003/0180266 A1, the disclosure of which is incorporatedherein by reference. “Growth factors” include but are not limited totransforming growth factor (TGF)-beta 1, TGF-beta 2, TGF-beta 3, bonemorphogenetic protein (BMP)-2, BMP-3, BMP-4, BMP-6, BMP-7, BMP-9,fibroblast growth factor (FGF), platelet derived growth factor (PDGF),insulin-like growth factor (ILGF); human endothelial cell growth factor(ECGF); epidermal growth factor (EGF); nerve growth factor (NGF); andvascular endothelial growth factor (VEGF). “Anti-IL-1” componentsinclude but are not limited to those described in U.S. PatentApplication Publication Nos. 2003/0220283 and 2005/0260159, the entiredisclosures of which are incorporated herein by reference. “Stem cellmaterial” includes but is not limited to dedifferentiated stem cells,undifferentiated stem cells, and mesenchymal stem cells. “Stem cellmaterial” also includes but is not limited to stem cells extracted frommarrow, which may include lipo-derived stem cell material andadipose-derived stem cell material, such as described in U.S.Publication Nos. 2004/0193274 and 2005/0118228, each of which isincorporated herein by reference. “Stem cell material” also includes butis not limited to stem cells derived from adipose tissue as described inU.S. Patent Application Publication Nos. 2003/0161816, 2004/0097867 and2004/0106196, each of which is incorporated herein by reference.

A “biologically active component” also includes but is not limited tocartilage derived morphogenetic protein (CDMP); cartilage inducingfactor (CIP); proteoglycans; hormones; and matrix metalloproteinases(MMP) inhibitors, which act to inhibit the activity of MMPs, to preventthe MMPs from degrading the extracellular matrix (ECM) produced by cellswithin the nucleus pulposus of the disc. Exemplary MMP inhibitorsinclude but are not limited to tissue inhibitors, such as TIMP-1 andTIMP-2. Certain MMP inhibitors are also described in U.S. PatentApplication Publication No. 2004/0228853, the entire disclosure of whichis incorporated herein by reference.

A “biologically active component” also includes but is not limited toallogenic or xenogenic disc annulus material, such as described in U.S.Patent Application Publication No. 2005/0043801, the entire disclosureof which is incorporated herein by reference; biologic tissues, such asthose described in U.S. Patent Application Publication No. 2003/0004574,the entire disclosure of which is incorporated herein by reference; anactivated tissue graft, such as described in U.S. Patent ApplicationPublication No. 2005/0136042, the entire disclosure of which isincorporated herein by reference; an engineered cell comprising anucleic acid for encoding a protein or variant thereof, such as a BMP, aLIM mineralization protein, or an SMAD protein as described in U.S.Patent Application Publication Nos. 2003/0219423 and 2003/0228292, theentire disclosures of which are incorporated herein by reference; and arecombinant human bone morphogenetic protein, such as described in U.S.Patent Application Publication No. 2004/0024081, the entire disclosureof which is incorporated herein by reference.

As used herein, a “biological additive” includes but is not limited to“biomaterial carriers”, “therapeutic agents”, “liquids” and“lubricants.”

“Biomaterial carriers” include but are not limited to collagen, gelatin,hyaluronic acid, fibrin, albumin, keratin, silk, elastin,glycosaminoglycans (GAGs), polyethylene glycol (PEG), polyethylene oxide(PEO), polyvinyl alcohol (PVA) hydrogel, polyvinyl pyrrolidone (PVP),co-polymers of PVA and PVP, other polysaccharides, platelet gel,peptides, carboxymethyl cellulose, and other modified starches andcelluloses. Collagen includes but is not limited to collagen-basedmaterial, which may be autogenic, allogenic, xenogenic or ofhuman-recombinant origin, such as the collagen-based material describedin U.S. Patent Application Publication Nos. 2004/0054414 and2004/0228901, the entire disclosures of which are incorporated herein byreference.

“Therapeutic agents” include but are not limited to nutrients,analgesics, antibiotics, anti-inflammatories, steroids, antiviricides,vitamins, amino acids and peptides. Nutrients include but are notlimited to substances that promote disc cell survival, such as glucoseand pH buffers, wherein the pH buffer provides a basic environment inthe disc space, which preferably will be a pH of about 7.4. Analgesicsinclude but are not limited to hydrophilic opoids, such as codeine,prodrugs, morphine, hydromorphone, propoxyphene, hydrocodone, oxycodone,meperidine and methadone, and lipophilic opoids, such as fentanyl.Antibiotics include but are not limited to erythromycin, bacitracin,neomycin, penicillin, polymyxin B, tetracyclines, viomycin,chloromycetin and streptomycins, cefazolin, ampicillin, azactam,tobramycin, clindamycin and gentamycin.

“Liquids” include but are not limited to water, saline andradio-contrast media. Radio-contrast media includes but is not limitedto barium sulfate, or a radio contrast dye, such as sodium diatrizoate(HYPAQUE™).

“Lubricants” include but are not limited to hyaluronic acid, a salt ofhyaluronic acid, sodium hyaluronate, glucosaminoglycan, dermatansulfate, heparin sulfate, chondroitin sulfate, keratin sulfate, synovialfluid, a component of synovial fluid, vitronectin and rooster combhyaluronate.

A biological treatment may be introduced to an area of a vertebralcolumn, such as a motion segment, by any method and in any formappropriate for such introduction. For example, the biological treatmentcan be injected, deposited, or applied, as a solution, a suspension,emulsion, paste, a particulate material, a fibrous material, a plug, asolid, porous, woven or non-woven material, or in a dehydrated orrehydrated state. Suitable forms for a biological treatment and suitablemethods for injecting a biological treatment include those described inU.S. Patent Application Publication Nos. 2005/0267577, 2005/0031666,2004/0054414, and 2004/0228901, each of which is incorporated herein byreference.

For example, referring now to FIG. 3, a biological treatment 30 may beinjected into the joint capsule 32 of a facet joint 34 through ahypodermic needle 36 attached to a syringe 38. The syringe 38 isinserted into the joint capsule 32, and the syringe plunger 40 isdepressed, thereby releasing the biological treatment into the jointcapsule of the facet joint. As illustrated by the arrows in FIG. 3, theneedle/syringe assembly may be moved around within the joint capsule,sweeping from side to side and back and forth, to ensure uniformdistribution of the biological treatment within the facet joint. It ispreferred, however, that the tip of the needle be maintained near thecenter of the joint capsule to ensure deposition of the material withinthe desired area, and to minimize potential leakage.

Referring now to FIG. 4, another method for injecting a biologicaltreatment into a facet joint is illustrated. According to the embodimentillustrated in FIG. 4, a biological treatment 42 is provided in the formof microspheres, powders, particulates, pellets, granules, a plug, asolid, porous, woven or non-woven material. Biological treatment 42 maybe compressed into a size suitable for delivery through a cannula 44 bypressure and/or heat and/or insertion through a small diameter tube. Thedelivery cannula 44 is attached to a dilator 46. The biologicaltreatment 42 is inserted into a facet joint 48 by penetrating thecapsule 50 of the facet joint with a guide needle 52. Dilator 46,preferably with delivery cannula 44 already attached, is inserted overguide needle 52. A plunger 54 may be used to push the biologicaltreatment from the cannula into the facet joint. The form of thebiological treatment may expand upon exiting the dilator, and mayfurther expand as it hydrates or rehydrates in the facet joint.

Referring now to FIG. 5, a method for injecting a biological treatmentinto a disc space is illustrated. According to the embodimentillustrated in FIG. 5, a biological treatment 56 may be injected intothe nucleus pulposus 58 contained within a disc annulus 60 in anintervertebral disc space 62. Biological treatment 56 is injectedthrough a hypodermic needle 64 attached to a syringe 66. The syringe 66is inserted into the nucleus pulposus, and the syringe plunger 68 isdepressed, thereby releasing the biological treatment into the discspace 62. As illustrated by the arrows in FIG. 5, the needle/syringeassembly may be moved around, sweeping from side to side and back andforth, to ensure uniform distribution of the biological treatment withinthe disc space. It is preferred, however, that the tip of the needle bemaintained near the center of the disc space to ensure deposition of thematerial within the nucleus of the disc, and to minimize potentialleakage.

Referring now to FIG. 6, another method for injecting a biologicaltreatment into a disc space is illustrated. According to the embodimentillustrated in FIG. 6, a biological treatment 68 is provided in the formof granules, a plug, a solid, porous, woven or non-woven material.Biological treatment 68 may be compressed into a size suitable forgdelivery through a cannula 70 by pressure and/or heat and/or insertionthrough a small diameter tube. The delivery cannula 70 is attached to adilator 72. The biological treatment 68 is inserted into the nucleuspulposus 74 by penetrating the annulus 76 of the disc with a guideneedle 78. Dilator 72, preferably with delivery cannula 70 alreadyattached, is inserted over guide needle 78. A plunger 80 may be used topush the biological treatment from the cannula into the nucleuspulposus. The form of the biological treatment may expand upon exitingthe dilator, and may further expand as it hydrates or rehydrates.

Referring now to FIGS. 7A-7F, a method of injecting a biologicaltreatment into a vertebral body and/or an endplate is illustrated.

With reference now to FIG. 7A, a channel 86 can be created in vertebralbody 84 through the pedicle using a suitable bone-penetrating implementsuch as a trocar needle 88. A sheath 90 (FIG. 7B) can be inserted intochannel 86 through which various procedures can be implemented. FIG. 7Cshows a subsequent step in which a flexible or otherwise steerabledevice 92, such as a needle or drill, is positioned through sheath 90 toaccess regions nearing the endplate of vertebral body 84. Although FIG.7C illustrates positioning sheath 90 to access regions near the endplateof vertebral body 84, sheath 90 could also be positioned so as to accessregions more central to the vertebral body itself, as opposed to theendplate.

Referring still to FIG. 7C, several directional passes of the steerabledevice 92 may be used in order to create access to a broader volume ofbone. The tip 93 of steerable device 92 can be designed so as to besteerable, for instance by rotation of steerable device 92. Asillustrated in FIG. 7D, after accessing near the endplate, (or to thevertebral body itself in other embodiments), the steerable device 92 canbe withdrawn, and a delivery device 94 can be inserted through sheath90. Delivery device 94 can have delivery tip 95, which is curved orotherwise steerable. Delivery device 94 can also include a reservoir 96and a plunger 97, allowing for the delivery of a biological treatment 98out of delivery tip 93. FIG. 7E shows an intermediate stage of thedelivery process in which additional amounts of the biological treatment98 are delivered as the sheath 90 and the delivery device 94 arewithdrawn from the access channel 86. In this manner, the access channel86 can be backfilled with the biological treatment 98 as the implementsare withdrawn. Finally, shown in FIG. 7F is the biological treatment 98occupying a volume overlying an endplate of the vertebral body 84, andalso backfilled into the access channel 86.

Referring now to FIGS. 8A-8C, another method of injecting a biologicaltreatment into a vertebral body and/or an endplate is illustrated.

With reference now to FIG. 8A, an access channel 200 is created invertebral body 202 just above the endplate using a bone-penetratingimplement 204, for example, a needle. After this access, a sheath 206 isprovided into channel 200. A delivery device 208 is then insertedthrough the lumen of sheath 206 and is used to deliver a biologicaltreatment 210 into the vertebral body in a volume overlying theendplate. If desired or needed, a steerable needle or drill can be usedto create access to a broader volume of bone, generally as described inconjunction with FIGS. 7A through 7F above. As well, a backfillingprocedure can be used to fill the access channel 200 as the deliverydevice 208 and sheath 206 are removed. As shown in FIG. 8C, ultimately,a volume of the biological treatment 210 is delivered into the vertebralbody overlying the endplate.

In other embodiments, a biological treatment may be introduced into anarea of a vertebral column, such as a motion segment, through aneedle/trocar assembly, as described in the above-referenced U.S. PatentApplication Publication Nos. 2005/0031666. In still other embodiments, abiological treatment may be introduced into an area of a vertebralcolumn by extrusion through a dilated annular opening, infusion througha catheter, insertion through an opening created by trauma or surgicalincision, or by other means of invasive or minimally invasive depositionof materials into the area receiving the biological treatment.

According to certain embodiments described herein, when treating avertebral column with a biological treatment, the load to be imposed onthe treated area and/or on surrounding areas is also considered. Forexample, it can be noted whether the load imposed on a motion segmentbeing treated would adversely affect the success of a biologicaltreatment applied to the motion segment in achieving the desired repair,regeneration, reduction or prevention. By reducing the load imposed onthe treated motion segment, the biological treatment is provided anopportunity to perform its function in an area that is less stressed,and therefore more receptive to the intended function of the biologicaltreatment.

Thus, to achieve an improved clinical outcome and a stable result,biological treatments are applied in one or more of the anterior region,anterior column region, posterior region, and spinous process region ofa vertebral column, while load-bearing devices and systems for treatmentof one or more of the anterior region, anterior column region, posteriorregion, and spinous process region are also applied to provide amechanical unloading of the region receiving the biological treatment.

Biological Treatment of Facet Joint and/or Disc Space Combined withAnterior Systems

Referring now to FIG. 9, a combined treatment of a vertebral motionsegment 100 with a biological treatment and a load-bearing device fortreatment of the anterior region 120 of the spine is illustrated.

A biological treatment 102 has been applied to facet joint 104 byinjection with an appropriately sized syringe/hypodermic needle assembly106. Selection of an appropriately sized syringe/hypodermic needleassembly for injection into the facet joints of a spine is within thepurview of one of ordinary skill in the art. Suitable methods forinjecting the biological treatment 102 into the facet joint 104 aredescribed above with respect to FIGS. 3 and 4. Other methods asdescribed herein and as are known to those of ordinary skill in the artmay also be used.

In the embodiment illustrated in FIG. 9, a biological treatment 108 hasalso been applied to disc space 110, which could include treatment ofeither or both of the nucleus pulposus and the annulus, with anappropriately sized hypodermic needle 112. Selection of an appropriatelysized hypodermic needle for injection into the disc space of a spine iswithin the purview of one of ordinary skill in the art. Suitable methodsfor injecting the biological treatment 108 into the disc space 116 aredescribed above with respect to FIGS. 5 and 6. Other methods asdescribed herein and as are known to those of ordinary skill in the artmay also be used.

Although two biological treatments 102 and 108 are illustrated, thepresent disclosure contemplates and includes application of just onebiological treatment, or of two or more biological treatments. Moreover,biological treatments can be applied in one or more of the anteriorlongitudinal ligament, the vertebral bodies, and the endplates of thevertebral bodies.

According to the embodiment illustrated in FIG. 9, the treatment offacet joint 104 and the disc space 110 with biological treatments 102and 108 is combined with an anterior device designed for treatment ofthe anterior region 120 of the vertebral motion segment 100. Theanterior device is represented in FIG. 9 by anterior device 114, howeverthe appearance of anterior device 114 is illustrative only, and it isunderstood that a wide variety of anterior devices could be used withthe present embodiments. Further, it is contemplated that separately orin combination with biological treatment 108, an interbody spacer (notshown) may be placed in the disc space to at least partiallymechanically unload the facet and/or a portion of the disc space.

Anterior device 114 may be an elastic anterior tension band, attachableto the adjacent vertebral bodies with bone screws 115. In otherembodiments, anterior device 114 could comprise any synthetic or naturaltissue based prostheses for replacing or supplementing the anteriorlongitudinal ligament. In still other embodiments, anterior device 114could comprise anterior bone fixation plates for the cervical, thoracic,or lumbar vertebral regions. Such plates may include those offered by ordeveloped by Medtronic, Inc. of Minneapolis, Minn. under brand namessuch as the ATLANTIS plate, PREMIER plate, ZEPHIR plate, MYSTIC plate,PYRAMID plate, or DYNALOK CLASSIC plate, CD HORIZON ECLIPSE.

Suitable anterior devices may be formed from a biocompatible materialselected from metals, polymers, ceramics, and tissue, and combinationsthereof. A suitable configuration could be a metal plate, such astitanium, titanium alloy, nickel titanium, tantalum, or stainless steelplate. Alternatively, anterior devices may be formed of elastomer-baseddevices, or polymeric composite-based devices that connect with two ormore vertebrae. Anterior devices may also be formed of less rigid ormore flexible materials such as polyaryletherketone (PAEK)-basedmaterials, which includes polyetheretherketone (PEEK),polyetherketoneketone (PEKK), PEEK-carbon composite, polyetherimide,polyimide, polysulfone, polyethylene, polyester, polylactide, copolymersof poly L-lactide and poly D-lactide, polyorthoester, tyrosinepolycarbonate, polypolyurethane, silicone, polyolefin rubber, etc., andcombinations thereof. In some embodiments, the anterior device may bebioresorbable or partially resorbable.

Anterior devices may also be formed of inelastic material, such asbraided tethers or woven textiles, for example polyester orpolyethylene, or of elastic material, such as rubber banding or plates,sheets, rods, or tubing made of silicone or polyurethane. In stillanother alternative, an anterior device may include annulus repair orreplacement devices for the anterior portion of the annulus.

The selected anterior device may be connected to two or more vertebralbodies or vertebral endplates through the use of any connectionmechanism such as bone screws, staples, sutures, or adhesives, or otherapplicable devices. The anterior device may be loaded in compression ortension depending upon the patient's indication or the performance ofbiological treatments, such as biological treatments 102 and/or 108. Forexample, an anterior plate may be installed in tension to beload-bearing with respect to facet joint 104, thereby reducing the loadon facet joint 104 where the biological treatment 102 was introduced.Such a technique can be further enhanced with the use of an interbodyspacer.

Biological Treatment of Facet Joint and/or Vertebral Body and/orEndplate Combined with Anterior Column Systems

Referring now to FIG. 10, a combined treatment of a vertebral motionsegment 130 with a biological treatment and a load-bearing device fortreatment of the anterior column region 142 of the spine is illustrated.

A biological treatment 132 has been introduced into facet joint 134 byinjection with an appropriately sized hypodermic needle 136. Selectionof an appropriately sized hypodermic needle for injection into the facetjoints of a spine is within the purview of one of ordinary skill in theart. Suitable methods for introducing biological treatment 132 into thefacet joint 134 are described above with respect to FIGS. 3 and 4. Othermethods as described herein and as are known to those of ordinary skillin the art may also be used.

In the embodiment illustrated in FIG. 10, biological treatments 138 and140 have also been applied to the vertebral bodies and endplates,respectively. Suitable methods for introducing biological treatments 138and 140 into the vertebral bodies and endplates are described above withrespect to FIGS. 7A-7F and 8A-8C. Other methods as described herein andas are known to those of ordinary skill in the art may also be used.

Although three biological treatments 132, 138 and 140 are illustrated,the present disclosure contemplates and includes application of just onebiological treatment, or of two or more biological treatments. Moreover,biological treatments can be applied in other areas of the spine, forexample, biological treatments can be applied to the disc space,including the nucleus and/or the annulus of the disc, and the anteriorlongitudinal ligament.

According to the embodiment illustrated in FIG. 10, the treatment offacet joint, the endplates and the vertebral bodies with biologicaltreatments is combined with an anterior column device designed fortreatment of the anterior column region 142 of the vertebral motionsegment 130. The anterior column device is represented in FIG. 10 by ananterior column device 146 designed for treatment of disc space 144,however the appearance of anterior column device 146 is illustrativeonly, and it is understood that a wide variety of anterior columndevices could be used with the present embodiments.

Anterior column device 146 may be a prosthetic motion-preserving disc,such as those offered by or developed by Medtronic, Inc. under brandnames such as MAVERICK, BRYAN, PRESTIGE, or PRESTIGE LP. Singlearticulating surface motion preserving discs may be disclosed more fullyin U.S. Pat. Nos. 6,740,118; 6,113,637; or 6,540,785, each of which isincorporated by reference herein. Double articulating surface motionpreserving discs may be disclosed more fully in U.S. Pat. Nos.5,674,296; 6,156,067; or 5,865,846, each of which is incorporated byreference herein.

In some embodiments, anterior column device 146 may be amotion-preserving interbody device that extends posteriorly from theinterbody space and includes features for providing posterior motion.These types of bridged systems may be disclosed in U.S. Pub. Pat. App.Nos. 2005/0171610; 2005/0171609; 2005/0171608; 2005/0154467;2005/0154466; 2005/0154465; 2005/0154464; 2005/0154461, each of which isincorporated by reference herein.

According to other embodiments, anterior column device 146 may includerigid fusion devices, such as those offered by or developed byMedtronic, Inc. of Minneapolis, Minn. under brand names such as INTERFIXcage, INTERFIX RP cage, LT cage, CORNERSTONE spacer, TELAMON spacer,MDII and MDIII threaded bone dowels, PRECISION GRAFT and PERIMETER ringspacers, etc.

According to still other embodiments, anterior column device 146 mayinclude a spherical, ellipsoidal or similarly shaped disc replacementdevice, which may be installed in the interbody space. Such devices mayinclude the SATELLITE system offered by or developed by Medtronic, Inc.This type of device may be described in detail, for example, in U.S.Pat. No. 6,478,822, which is incorporated by reference herein.

In still another embodiment, anterior column device 146 may be anelastically deformable device comprising a resilient or an elastomericmaterial such as silicone, polyurethane, polyolefin rubber or aresilient polymer, and/or may comprise a mechanical spring component.Such elastically deformable devices include those with an elastomericcore disposed between rigid outer plates, as described for example, inU.S. Pat. Nos. 6,669,732; 6,592,664 and 6,162252, each of which isincorporated by reference. Such devices may also include the ACROFLEXlumber disc offered by or developed by Depuy-Acromed, Inc. In someembodiments, the anterior column device may be bioresorbable orpartially resorbable.

In still other embodiments, anterior column device 146 may includeinterbody motion-preserving devices, such as nucleus replacementimplants that work in conjunction with all or portions of the naturalannulus. Such nucleus replacement implants may include those offered byor developed by Medtronic, Inc under a brand name such as NAUTILUS oroffered by or developed by Raymedica, Inc. of Minneapolis, Minn. underbrand names such as PDN-SOLO® and PDN-SOLO XL™. These types of nucleusreplacement implants may be described in detail in, for example, U.S.Pat. Nos. 6,620,196 and 5,674,295, each. of which is incorporated byreference herein. Injectable nucleus replacement material including apolymer based system such as DASCOR™ by Disc Dynamics of Eden Prairie,Minn. or a protein polymer system such as NuCore™ Injectable Nucleus bySpine Wave, Inc. of Shelton, Conn. may be alternatives for preservinginterbody motion.

In still other embodiments, anterior column device 146 comprises adevice for treating a vertebral body in the anterior column region ofthe spine. Devices for treating a vertebral body that are suitable forcombination with the methods described herein include void creationdevices and vertebral compression fracture realignment devices forvertebral body repair, such as balloon expansion systems offered by ordeveloped by Kyphon, Inc. of Glendale, Calif. Examples of such balloonexpansion systems are disclosed in U.S. Pub. Nos. 2004/0102774 and20040133280 and U.S. Pat. Nos. 4,969,888 and 5,108,404, all of which areincorporated by reference herein. Other void creation devices thatutilize expandable cages or displacement systems may also be used forvertebral body repair. Such additional void creation systems may bedisclosed in U.S. Published Pat. App. No. 2004/0153064 and 2005/0182417and are incorporated by reference herein. In still another alternative,vertebral body replacement devices or corpectomy devices may be used toreplace an entire vertebrae or series of vertebrae. Such corpectomysystems may be of the type disclosed, for example, in U.S. Pat. Nos.5,702,453; 5,776,197; 5,5776,198; or 6,344,057, each of which isincorporated by reference herein.

In still further embodiments, anterior column device 146 comprises adevice for treating an endplate of a vertebral body in the anteriorcolumn region of the spine. Devices for treating an endplate that aresuitable for combination with the methods described herein include butare not limited to endplate supplementation systems that use rigid orflexible devices such as metal plates with spikes or other attachmentmechanisms to anchor the plates to existing bony tissue.

Anterior column device 146 may be formed from biocompatible materialssuch as metals, polymers, ceramics, and tissue, and combinationsthereof. In certain embodiments, anterior column device 146 may beresorbable or partially resorbable.

Any of the foregoing anterior column devices may be combined with anybiological treatment. For example, in certain embodiments, a biologicaltreatment comprising injectable collagen containing stem cells and BMP-6is applied to a facet joint in a vertebral column. A nucleus replacementimplant such as a NAUTILUS brand implant (Medtronic, Inc.) is insertedinto the nucleus of a disc adjacent to the facet joint receiving thebiological treatment to provide a mechanical unloading to the treatedfacet joint.

In other embodiments, a biological treatment comprising an injectablepolyvinyl alcohol hydrogel containing chondrocytes and TGF-beta 2 isapplied to a facet joint. A prosthetic motion-preserving disc, such as aMAVERICK brand implant (Medtronic, Inc.) is inserted into the disc spaceadjacent to the facet joint receiving the biological treatment toprovide a mechanical unloading to the treated facet joint.

In still other embodiments, a biological treatment comprising injectablepolyethylene glycol gel containing fibroblasts and TGF-beta is appliedto a facet joint. An injectable collagen is inserted into the disc spaceadjacent to the facet joint receiving the biological treatment toprovide a mechanical unloading to the treated facet joint.

In yet other embodiments, a biological treatment comprising aninjectable porcine-based collagen containing anti-TNF alpha and ILGF isapplied to a facet joint. An injectable nucleus replacement material,such as the polymer based system DASCOR™ (Disc Dynamics) is applied tothe disc space adjacent to the facet joint receiving the biologicaltreatment to provide a mechanical unloading to the treated facet joint.

Anterior column device 146 may be loaded in compression or tensiondepending upon the patient's indication or the performance of otherimplanted systems or treatments. These interbody systems may provide adesired level of intervertebral disc space distraction, depending uponthe patient's indication. For example, an interbody device or system maybe sized or filled to reduce the load on the facet joint 134 where thebiological treatment 132 was introduced.

According to one embodiment, a procedure for performing the methodsdescribed herein includes surgically accessing at least a portion of apatient's spine, and implanting a load-bearing device in the patient'sspine. In one aspect, the load-bearing device is implanted so as tomechanically unload all or a portion of the facet joint and/or the discspace, which receives a biological treatment. In another aspect, theload-bearing device is implanted into an area of the spine that isintact, for example, a motion segment where the anatomy has not beensurgically disrupted. In another aspect, the anatomy of the area of thespine in which the load-bearing device is being implanted has beensurgically disrupted, for example, a resection of the facet or thespinous process, or even a discectomy, has been performed.

Whether the spinal anatomy is intact or has been disrupted, theload-bearing device is device is implanted in to the spine in a positionso as to be at least partially load-bearing with respect to the areathat is to receive a biological treatment. The device thus mechanicallyunloads all or a portion of the area to receive the biologicaltreatment. For example, a motion-preserving device may be placed in thedisc space located in the anterior column portion of the spine totransfer load away from the disc space and/or the facets. In one aspect,the facet joints and/or the adjacent vertebral bodies surrounding thedisc space are mechanically moved by placement of the mechanicalunloading device to align the facet joint and/or increase the distancebetween the adjacent vertebral bodies. After application of themechanical unloading device, a biological treatment is applied to atleast one facet and/or the disc space. In another aspect, theabove-described steps may be reversed such that the biological treatmentof the facet joint and/or the disc space occurs first, and themechanical unloading occurs later.

Although only a few exemplary embodiments have been described in detailabove, those skilled in the art will readily appreciate that manymodifications are possible in the exemplary embodiments withoutmaterially departing from the novel teachings and advantages of thisdisclosure. Accordingly, all such modifications and alternative areintended to be included within the scope of the invention as defined inthe following claims. Those skilled in the art should also realize thatsuch modifications and equivalent constructions or methods do not departfrom the spirit and scope of the present disclosure, and that they maymake various changes, substitutions, and alterations herein withoutdeparting from the spirit and scope of the present disclosure.

For example, each of the following patent applications are incorporatedherein by reference, as each describes spinal devices that can beapplied to the anterior, anterior column, posterior, or spinous processregions of the vertebral column, and that can be used to unload an areatreated with a biological treatment as described herein. Attorney DocketTitle No. Filing Date Inventor(s) Materials, Devices, and P22656.00 Jan.13, 2006 Hai H. Trieu Methods for Treating 31132.378 Multiple SpinalRegions Including The Interbody Region Materials, Devices, and P22578.00Jan. 13, 2006 Hai H. Trieu Methods for Treating 31132.376 MultipleSpinal Regions Including The Posterior and Spinous Process RegionsMaterials, Devices, and P22615.00 Jan. 13, 2006 Hai H. Trieu Methods forTreating 31132.377 Multiple Spinal Regions Including The AnteriorRegion. Materials, Devices, and P22681.00 Jan. 13, 2006 Hai H. TrieuMethods for Treating 31132.379 Multiple Spinal Regions IncludingVertebral Body and Endplate Regions Use Of A Posterior P22397.00 Jan.13, 2006 Aure Bruneau et Dynamic Stabilization 31132.420 al. System WithAn Interdiscal Device

In addition, each of the following applications describes suitablebiological treatments that can be applied to an area of the vertebralcolumn, and spinal devices that can be applied to the anterior, anteriorcolumn, posterior, or spinous process regions of the vertebral column tounload the treated area. Each of the following applications was filedconcurrently with the present application, assigned to the sameassignee, and each is hereby incorporated by reference. Attorney DocketTitle No. Filing Date Inventor(s) Treatment of the P23558.00 concurrentwith Hai H. Trieu Vertebral Column 31132.476 the present applicationTreatment of the P23556.00 concurrent with Hai H. Trieu Vertebral Column31132.474 the present application Treatment of the P23557.00 concurrentwith Hai H. Trieu Vertebral Column 31132.475 the present applicationBiological Fusion P23568.00 concurrent with Hai H. Trieu in theVertebral 31132.478 the present Mike Sherman Column applicationTreatment of the P23559.00 concurrent with Hai H. Trieu Vertebral Column31132.477 the present application

It is understood that all spatial references, such as “horizontal,”“vertical,” “top,” “inner,” “outer,” “bottom,” “left,” “right,”“anterior,” “posterior,” “superior,” “inferior,” “upper,” and “lower”are for illustrative purposes only and can be varied within the scope ofthe disclosure. In the claims, means-plus-function clauses are intendedto cover the elements described herein as performing the recitedfunction and not only structural equivalents, but also equivalentelements.

1. A method of treating a vertebral column comprising: introducing abiological treatment into at least one area of a vertebral columnselected from a facet joint, a disc space, a vertebral body and anendplate; and at least partially mechanically unloading the treated areaby applying a load-bearing device to at least an anterior column regionof the vertebral column.
 2. The method of claim 1 wherein the biologicaltreatment comprises a biologically active component.
 3. The method ofclaim 2 wherein the biological treatment further comprises a biologicaladditive.
 4. The method of claim 3 wherein the biological additivecomprises at least one of a biomaterial carrier, a therapeutic agent, aliquid and a lubricant.
 5. The method of claim 3 wherein the biologicaladditive is selected from autogenic collagen, allogenic collagen,xenogenic collagen, human recombinant collagen, gelatin, hyaluronicacid, fibrin, albumin, keratin, silk, elastin, glycosaminoglycans(GAGs), polyethylene glycol (PEG), polyethylene oxide (PEO), polyvinylalcohol (PVA) hydrogel, polyvinyl pyrrolidone (PVP), co-polymers of PVAand PVP, polysaccharides, platelet gel, peptides, carboxymethylcellulose, modified starches and celluloses.
 6. The method of claim 3wherein the biological additive is selected from nutrients, analgesics,antibiotics, anti-inflammatories, steroids, antiviricides, vitamins,amino acids and peptides.
 7. The method of claim 6 wherein thebiological additive comprises at least one of: an analgesic selectedfrom codeine, prodrugs, morphine, hydromorphone, propoxyphene,hydrocodone, oxycodone, meperidine, methadone, and fentanyl; and anantibiotic selected from erythromycin, bacitracin, neomycin, penicillin,polymyxin B, tetracyclines, viomycin, chloromycetin, streptomycins,cefazolin, ampicillin, azactam, tobramycin, clindamycin and gentamycin.8. The method of claim 3 wherein the biological additive is selectedfrom water, saline, radio-contrast media, hyaluronic acid, a salt ofhyaluronic acid, sodium hyaluronate, glucosaminoglycan, dermatansulfate, heparin sulfate, chondroitin sulfate, keratin sulfate, synovialfluid, a component of synovial fluid, vitronectin and rooster combhyaluronate.
 9. The method of claim 1 wherein the biological treatmentcomprises a biologically active component selected from anti-cytokines;anti-interleukin-1 components (anti-IL-1); anti-TNF alpha; growthfactors; LIM mineralization proteins; stem cell material, autogenicchondrocytes; allogenic chondrocytes, autogenic chondrocytes with one ofa retroviral viral vector or a plasmid viral vector; allogenicchondrocytes with one of a retroviral viral vector or a plasmid viralvector; and fibroblasts;
 10. The method of claim 1 wherein thebiological treatment comprises a biologically active component selectedfrom transforming growth factors, bone morphogenetic proteins,fibroblast growth factors, platelet derived growth factor (PDGF),insulin-like growth factor (ILGF); human endothelial cell growth factor(ECGF); epidermal growth factor (EGF); nerve growth factor (NGF); andvascular endothelial growth factor (VEGF).
 11. The method of claim 10wherein the biologically active component comprises at least one of atransforming growth factor selected from TGF-beta 1, TGF-beta 2, andTGF-beta 3, and a bone morphogenetic protein selected from BMP-2, BMP-3,BMP-4, BMP-6, BMP-7, and BMP-9.
 12. The method of claim 1 wherein thebiological treatment comprises stem cell material selected fromdedifferentiated stem cells, undifferentiated stem cells, mesenchymalstem cells, marrow-extracted stem cell material and adipose-derived stemcell material.
 13. The method of claim 1 wherein the biologicaltreatment comprises a biologically active component selected fromcartilage derived morphogenetic protein (CDMP); cartilage inducingfactor (CIP); proteoglycans; hormones; and matrix metalloproteinases(MMP) inhibitors.
 14. The method of claim 1 wherein the biologicaltreatment comprises a biologically active component selected fromallogenic disc annulus material, xenogenic disc annulus material,biologic tissues, activated tissue grafts, engineered cells comprising anucleic acid for encoding a protein or variant thereof, and arecombinant human bone morphogenetic protein.
 15. The method of claim 1wherein the load-bearing device is bioresorbable or partiallyresorbable.
 16. The method of claim 1 wherein the treated area comprisesa facet joint.
 17. The method of claim 1 wherein the spinal devicecomprises at least one of a prosthetic motion-preserving system, afusion system, a disc replacement system, a disc nucleus replacementsystem, vertebral body repair system and an endplate supplementationsystem.
 18. The method of claim 1 wherein: the area of the vertebralcolumn receiving the biological treatment comprises a facet joint; thebiological treatment comprises collagen containing stem cells and BMP-6;and the spinal device comprises a nucleus replacement implant insertedinto the nucleus of a disc adjacent to the facet joint receiving thebiological treatment.
 19. The method of claim 1 wherein: the area of thevertebral column receiving the biological treatment comprises a facetjoint; the biological treatment comprises a polyvinyl alcohol hydrogelcontaining chondrocytes and TGF-beta 2; and the spinal device comprisesa prosthetic motion-preserving disc inserted into the disc spaceadjacent to the facet joint receiving the biological treatment.
 20. Themethod of claim 1 wherein: the area of the vertebral column receivingthe biological treatment comprises a facet joint; the biologicaltreatment comprises a polyethylene glycol gel containing fibroblasts andTGF-beta; and the spinal device comprises collagen inserted into thedisc space adjacent to the facet joint receiving the biologicaltreatment.
 21. The method of claim 1 wherein: the area of the vertebralcolumn receiving the biological treatment comprises a facet joint; thebiological treatment comprises a porcine-based collagen containinganti-TNF alpha and ILGF; and the spinal device comprises a nucleusreplacement material applied to the disc space adjacent to the facetjoint receiving the biological treatment.
 22. The method of claim 1wherein the biological treatment is non load-bearing.
 23. A method fortreating a motion segment of a spinal column comprising: accessing aportion of a patient's spinal column; implanting a load-bearing devicein an anterior column region of the spinal column to at least partiallymechanically unload an intact motion segment in the spinal column,wherein the intact motion segment comprises a facet joint; and injectinga biological treatment into the facet joint.
 24. The method of claim 23wherein the load-bearing device is implanted at a location in the spinethat is spaced from the motion segment receiving the biologicaltreatment.
 25. The method of claim 23 wherein the load-bearing device isimplanted at a location in the spine that is adjacent to the motionsegment receiving the biological treatment.